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June 19, 2014, Trial News

Device used in gynecological surgeries could spread cancer

Alyssa E. Lambert

As many as two dozen products liability cases have been filed against manufacturers of laparoscopic power morcellators, which are used to slice and remove uterine fibroids. Plaintiffs allege the devices can spread a dangerous hidden cancer from the uterus to other parts of the body.

Technological advances in medical devices can usher in unforeseen complications. Between one dozen and two dozen products liability cases, including at least one for wrongful death, have been filed against manufacturers of laparoscopic power morcellators. These bladed tools are used to slice and remove uterine fibroids, and plaintiffs allege the devices can spread a dangerous hidden cancer from the uterus to other parts of the body. Attorneys handling the cases said more lawsuits are likely to follow.

In April, the FDA issued a safety advisory discouraging hospitals and doctors from using the devices and instructing manufacturers to review their current labels for accurate risk information and warnings. Next month, the agency will evaluate the devices further, including deciding whether to place a “black box” warning on all power morcellators regarding the risk of spreading cancer. Although the FDA has been fairly critical of the devices’ risks, the American College of Obstetricians and Gynecologists (ACOG) issued a report last month defending their use, and the medical community appears divided on the issue.

According to the FDA advisory, 1 in 350 women undergoing surgery for fibroid removal or a hysterectomy have a uterine sarcoma, an undetected tumor that is a type of uterine cancer. During surgery to remove uterine fibroids—usually as part of a hysterectomy—morcellators can spread the cancerous tissue throughout the body. This spread can “upstage” the cancer from stage 1 to stage 4, which greatly reduces a woman’s long-term survival rate and decreases her quality of life.

On July 10 and 11, the agency will convene a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to discuss the devices’ clinical role in treating and removing uterine tumors and whether alternative surgical techniques or the use of accessories, such as specimen bags to collect the tissue that is removed, may make the device safer. In the meantime, the FDA recommended surgeons explore alternatives, because there is no reliable way to detect the cancer before surgery.

Johnson & Johnson, the largest morcellator manufacturer, has suspended global sales, but ACOG is defending continued use of the device, saying the procedure spares the patient more invasive surgery. Because the FDA advisory is nonbinding, doctors and hospitals are staunchly divided—some have ceased using the device completely, and some said the risk is minimal and agree with ACOG.

The devices have spurred more than a handful of lawsuits by women who developed uterine cancer after undergoing surgery with power morcellators. They allege that manufacturers knew or should have known about the risk of spreading cancer but failed to issue adequate warnings or make the device safer. They have asserted claims for negligence, strict products liability, breach of express and implied warranties, and fraudulent misrepresentation and omission.

In one of the first lawsuits filed, Donna Burkhart underwent a robotic hysterectomy in March 2012. Before the surgery, there was no evidence of cancer, but within 10 days of the surgery, doctors told her she had uterine cancer, and she died less than a year later. (Burkhart v. LiNA Med. U.S., No. 5:14-cv-01557-EGS (E.D. Pa. filed Mar. 14, 2014).) Brenda Leuzzi had a robotic hysterectomy in September 2012 and was diagnosed with cancer after the surgery. She is undergoing aggressive treatment since the cancer spread throughout her peritoneal cavity. (Leuzzi v. Ethicon Endo Surgery, Inc., No. 6:14-cv-06218 (W.D.N.Y. filed May 1, 2014).)

“These cases are about when did they know about the risk, what did they do about it, and why did they not make more of an issue about it?,” said Birmingham, Ala., attorney Francois Blaudeau, who represents several of the plaintiffs. “They developed these intracranial ballistic bags as a solution, and they just didn’t deploy it.”

Blaudeau, a practicing gynecological surgeon who has used morcellators in thousands of cases, said the manufacturers didn’t adequately inform the surgeons about the risk. “They want to give you the shiny new toy and tell you to go use it. They don’t want to say: ‘This is a great device, but oh, by the way, there is a potential to spread cancer if there is cancer there.’ It’s a difficult conversation the manufacturers did not want to have,” he said.

Blaudeau noted that the specimen bag and more warnings could have spared his clients. “Almost all these patients die within two years, and they die an ugly death,” he said. “That all could have been avoided.”

Birmingham attorney Kristian Rasmussen said he has been contacted by more than 100 victims and family members about the devices. He noted the apparent division between the FDA and ACOG. “You have to look at the ultimate interest of each organization, and ACOG’s interest is, first and foremost, protecting its members—i.e., the surgeon gynecologists performing these surgeries,” he said.

Blaudeau and Rasmussen agreed that although it is early in the litigation, it is clear that the manufacturers knew for years about the device’s risk of spreading cancer. Still, the cases will present challenges.

“While specific causation is always an issue, it will be a particularly important hurdle in this litigation,” said Rasmussen.

“These are tough cases to win,” said Blaudeau. “Unfortunately, juries look at them and say the patients would have died anyway.”